In-process control for PET radiopharmaceuticals

为了确保几种PET放射性药物的有效性和安全性，进行了过程中的控制。通过使用这项技术，制造工艺得到了优化，将放射性核素杂质的数量保持在最低限度。当使用钛靶室时，在靶水中检测到大量来自靶室组成金属的放射性核素杂质。但在后续的提纯或分离过程中，杂质几乎被完全消除。固相萃取技术比旋转蒸发技术获得了高质量的无杂质进样。

In process of control was conducted to assure the efficacy and safety for several PET radiopharmaceuticals. By using this technique, the manufacturing process was optimized to keep the amounts of radionuclidic impurities to a m inimum. Significant amounts of radionuclidic impurities from the constitute metal of target chamber were detected in the target water when using a titanium target chamber. However, the impurities were almost completely eliminated subsequent purification or separated process. Solid phase extraction technique for the final formulation gave high -quality injection without impurities over rotary evaporation technique.